FDA 510(k)

Jmoon FlexGlow 光療設備 (JD20U SP, JD20U SG)

K 號：K251825 · 2025-10-01

申請人Shenzhen Ulike Smart Electronics Co., Ltd.

決定日期2025-10-01

產品代碼OHS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K251825. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)?

Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K251825.

When did Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) receive FDA 510(k) clearance?

Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) received FDA 510(k) clearance on 2025-10-01, under 510(k) number K251825.

Who is the listed applicant for Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)?

The FDA 510(k) record lists Shenzhen Ulike Smart Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)?

The FDA product code for Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) is OHS.

其他以 Shenzhen Ulike Smart Electronics Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261325冰冷光療脫毛設備 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)K260742冰冷光療脫毛設備 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)K260511Ulike 回光光療設備 (UM10)K252804冰冷光脫毛設備 (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG; UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06RD, UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL)K251984冰冷光療脫毛設備 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)K250942冰冷光療脫毛設備 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

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相關器械（代碼：OHS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260767臉部美顏設備（臉部面膜LED美顏設備 A-901；臉部LED & EMS美顏設備 A-902；臉部面膜LED & EMS美顏設備 A-907）Kam Yuen Plastic Products , Ltd.K261602眼復原專家 (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光療面膜（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED光療治療面膜（JML1，JML1+JML2）；LED光療治療面膜（JML3，JML3+JML4）；LED光療治療面膜（JML5，JML5+JML7）；LED光療治療面膜（JML6，JML6+JML8）；LED光療治療面膜（JML9，JML9+JML10）Shenzhen Qianyu Technology Co., Ltd.K261496LED光療面膜（PE748、PE749、PE756）Duplex International Trading Limited K261482LightStim 經皮光療機（1984年）；LightStim 痤瘡光療機（2038年）Led Intellectual Properties, LLC

官方來源

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